NITROLINGUAL- nitroglycerin spray

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)

Disponível em:

Espero Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

NITROGLYCERIN

Composição:

NITROGLYCERIN 400 ug

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Nitrolingual Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. Do not use Nitrolingual Pumpspray in patients who are taking PDE-5-Inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see Drug Interactions (7.1) ]. Do not use Nitrolingual Pumpspray in patients who are taking soluble guanylate cyclase (sGC) stimulators, such as riociguat. Concomitant use can cause hypotension. Nitrolingual Pumpspray is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). Nitrolingual Pumpspray  may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e. g. cerebral hemorrhage or traumatic brain injury). Nitrolingual Pumpspray is contraindicated in patients who are allergic t

Resumo do produto:

Each box of Nitrolingual Pumpspray contains one glass bottle coated with red transparent plastic which assists in containing the glass and medication should the bottle be shattered. Each bottle contains 4.9 g or 14.1 g (Net Contents) of nitroglycerin lingual spray which will deliver 60 or 200 metered sprays containing 400 mcg of nitroglycerin per spray after priming. Nitrolingual Pumpspray is available as: Store at 20°C - 25°C (68°F - 77°F); excursions permitted to 15 - 30°C (59 - 86°F) [see USP Controlled Room Temperature]. Note: Nitrolingual Pumpspray contains 20 % alcohol. Do not forcefully open or burn container after use. Do not spray toward flames. Rx Only.

Status de autorização:

New Drug Application

Características técnicas

NITROLINGUAL- NITROGLYCERIN SPRAY
ESPERO PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NITROLINGUAL® PUMPSPRAY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NITROLINGUAL
PUMPSPRAY.
NITROLINGUAL® PUMPSPRAY (NITROGLYCERIN) LINGUAL SPRAY
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Nitrolingual Pumpspray is a nitrate vasodilator indicated for acute
relief of an attack or prophylaxis of angina pectoris due to
coronary artery disease (1).
DOSAGE AND ADMINISTRATION
At the onset of an attack, administer onto or under the tongue. Repeat
every 5 minutes as needed (2.1).
Do up to three metered sprays within a 15-minute period. If chest pain
persists, advise prompt medical attention (2.1).
May be used prophylactically 5 to 10 minutes prior to engaging in
activities that might precipitate an acute attack (2.1).
DOSAGE FORMS AND STRENGTHS
Lingual spray, 400 mcg per spray, available in 60 or 200 metered
sprays per container (3).
CONTRAINDICATIONS
Use of phosphodiesterase type 5 (PDE-5) Inhibitors, such as avanafil,
sildenafil, tadalafil, or vardenafil, or soluble
guanylate cyclase (sGC) stimulator (riociguat). (4.1, 7.1)
Severe anemia. (4.2)
Increased intracranial pressure. (4.3)
Hypersensitivity to Nitrolingual Pumpspray or to other nitrates or
nitrites or any excipient. (4.4)
WARNINGS AND PRECAUTIONS
Tolerance: Excessive use may lead to tolerance. (5.1)
Hypotension: Severe hypotension may occur. (5.2)
ADVERSE REACTIONS
Most common adverse reactions occurring at a frequency greater than 2
% are headache, dizzinesss and paresthesia (6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ESPERO PHARMACEUTICALS,
INC. AT 1-800-235-6520 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Antihypertensives: possible additive hypotensive effects. (7.2)
Ergotamine: increased bioavailability of ergotamine. Avoid concomitant
use (7.3)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
RE